2 EMI Consideration
IEC60601-1-2 Electromagnetic Standard Compliance & Documentation
The information contained in this section is also found in the Innova system Operator Manual.
2.1 General Scope
This equipment complies with IEC-60601-1-2: Edition 2.1 and Edition 3 standard for medical
devices
The Innova system is suitable to be used in the electromagnetic environment, as per the limits &
recommendations described in the tables here after:
•
Emission Compliance level & limits (Table 3-1).
•
Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 3-2,Table 3-3 and Table 3-4).
NOTE: This system complies with above–mentioned EMC standard when used with supplied
cables up to maximum lengths referenced in the MIS MAPS or system cables
interconnect diagrams.
2.2 Electromagnetic Emission
The Innova system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Innova system should assure that it is used in such an
environment.
Table 3-1:
Emissions Test Compliance Electromagnetic Environment
Radio-Frequency
Emissions
CISPR11
Group1 Class A
limits
The Innova system uses Radio Frequency energy only for its internal function.
Therefore, its Radio Frequency emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The Innova system is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable The Innova system is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable
The Innova system is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
2.3 Electromagnetic Immunity
2.3.1 Electromagnetic Immunity IEC 60601-1-2
The Innova system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Innova system should assure that it is used in such an
environment.
Innova
TM
IGS 520, Innova
TM
IGS 530, Innova
TM
IGS 540 Pre-Installation Manual
Direction 5499972-1-1EN, Revision 2
180 2 EMI Consideration
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